{"id":"gm-csf","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"Reported 25 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 22 times"},{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"Reported 20 times"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 18 times"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"Reported 18 times"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"Reported 17 times"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"Reported 17 times"},{"date":"","signal":"PANCYTOPENIA","source":"FDA FAERS","actionTaken":"Reported 16 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 15 times"},{"date":"","signal":"ATRIAL FIBRILLATION","source":"FDA FAERS","actionTaken":"Reported 14 times"}],"drugInteractions":[{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Corticosteroids","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Aspirin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Anticoagulants","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cytarabine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Thrombolytics","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Antiplatelet agents","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infection"},{"drug":"Corticosteroids","action":"Monitor","effect":"Increased risk of infection"},{"drug":"Immunosuppressants","action":"Monitor","effect":"Increased risk of infection"},{"drug":"Live vaccines","action":"Avoid","effect":"Increased risk of infection"},{"drug":"Corticosteroids","action":"Monitor","effect":"Increased risk of osteoporosis"},{"drug":"Thiazide diuretics","action":"Monitor","effect":"Increased risk of osteoporosis"},{"drug":"Glucocorticoids","action":"Monitor","effect":"Increased risk of osteoporosis"},{"drug":"Corticosteroids","action":"Monitor","effect":"Increased risk of cataracts"},{"drug":"Glucocorticoids","action":"Monitor","effect":"Increased risk of cataracts"},{"drug":"Corticosteroids","action":"Monitor","effect":"Increased risk of glaucoma"},{"drug":"Glucocorticoids","action":"Monitor","effect":"Increased risk of glaucoma"}],"contraindications":["Hypersensitivity to GM-CSF or any component of the formulation","Severe renal impairment","Severe hepatic impairment","Active infection","Malignancy","Pregnancy and breastfeeding"]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=gm-csf","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:55:29.882491+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Gm-Csf","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:55:37.208797+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:55:45.951950+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:55:35.588305+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=gm-csf","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:55:36.082030+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL216657/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:55:36.808019+00:00"}},"offLabel":[],"timeline":[{"date":"1985-01-01","type":"neutral","_source":"Wikipedia","milestone":"GM-CSF first cloned","regulator":"none"},{"date":"2002-01-01","type":"neutral","_source":"Wikipedia","milestone":"Novartis sold rights to Schering-Plough","regulator":"none"}],"aiSummary":"GM-CSF, marketed by Pfizer, is a cytokine-based therapy indicated for adult patients with Philadelphia chromosome-positive Chronic Myeloid Leukemia (CML) who are refractory or resistant to at least one prior tyrosine kinase inhibitor (TKI) therapy. Its key strength lies in its mechanism of action, which stimulates the production of granulocytes and macrophages, providing an alternative treatment option for patients who have failed TKI therapies. The primary risk is the competitive landscape, with established alternatives such as Filgrastim, Sargramostim, and Oprelvekin, which may limit market share.","brandName":"Gm-Csf","ecosystem":[],"isGeneric":true,"mechanism":{"target":"GM-CSF receptor","novelty":"me-too","modality":"biological","drugClass":"cytokine","explanation":"","oneSentence":"","technicalDetail":"GM-CSF acts by binding to its receptor, which triggers a signaling cascade that leads to the production of granulocytes and macrophages. This process is essential for the immune system's ability to fight infections and diseases. The drug's mechanism of action is complex and involves multiple cellular pathways."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Granulocyte-macrophage colony-stimulating factor","extract":"Granulocyte-macrophage colony-stimulating factor (GM-CSF), also known as colony-stimulating factor 2 (CSF2), is a monomeric glycoprotein secreted by macrophages, T cells, mast cells, natural killer cells, endothelial cells and fibroblasts that functions as a cytokine. The pharmaceutical analogs of naturally occurring GM-CSF are called sargramostim and molgramostim.","wiki_history":"== History ==\n\nGM-CSF was first cloned in 1985, and soon afterwards three potential drug products were being made using recombinant DNA technology: molgramostim was made in Escherichia coli and is not glycosylated, sargramostim was made in yeast, has a leucine instead of proline at position 23 and is somewhat glycosylated, and regramostim was made in Chinese hamster ovary cells (CHO) and has more glycosylation than sargramostim.  The amount of glycosylation affects how the body interacts with the drug and how the drug interacts with the body.\n\nAt that time, Genetics Institute, Inc. was working on molgramostim, Immunex was working on sargramostim (Leukine), and Sandoz was working on regramostim.\n\nMolgramostim was eventually co-developed and co-marketed by Novartis and Schering-Plough under the trade name Leucomax for use in helping white blood cell levels recover following chemotherapy, and in 2002 Novartis sold its rights to Schering-Plough.\n\nSargramostim was approved by the US FDA in 1991 to accelerate white blood cell recovery following autologous bone marrow transplantation under the trade name Leukine, and passed through several hands, ending up with Genzyme, which was subsequently acquired by Sanofi. Leukine is now owned by Partner Therapeutics (PTx).\n\nImlygic was approved by the US FDA in October 2015, and in December 2015 by the EMA, as an oncolytic virotherapy, commercialized by Amgen Inc. This oncolytic herpes virus, named Talimogene laherparepvec, has been genetical"},"commercial":{"yoyGrowth":"7%","launchDate":"1991","annualCostUS":"Generic pricing varies by manufacturer","_launchSource":"Wikipedia (original approval 1991), FDA earliest on record: 9999","genericStatus":"Biologic — patent protected","currentRevenue":"","patientPopulation":"Generic — multiple manufacturers","peakSalesEstimate":""},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=gm-csf","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=gm-csf","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://en.wikipedia.org/wiki/gm-csf","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":6,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_emaChecked":true,"_tgaChecked":true,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-19T23:55:45.952034+00:00","fieldsConflicting":1,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Neupogen","company":"Amgen","advantage":"Longer duration of action compared to GM-CSF","genericName":"Filgrastim"},{"name":"Leukine","company":"Merck KGaA","advantage":"More potent and longer-acting than GM-CSF","genericName":"Sargramostim"},{"name":"Neumega","company":"Wyeth Pharmaceuticals","advantage":"Used for a different indication (thrombocytopenia) but has a similar mechanism of action","genericName":"Oprelvekin"},{"name":"Nivestim","company":"Sandoz","advantage":"Generic version of Neupogen, offering a more affordable option","genericName":"Filgrastim"},{"name":"Zarxio","company":"Sandoz","advantage":"Generic version of Neupogen, offering a more affordable option","genericName":"Filgrastim-sndz"}],"genericName":"gm-csf","indications":{"approved":[{"name":"Chronic Myeloid Leukemia (CML) in adult patients with Philadelphia chromosome-positive (Ph+) disease who are refractory or resistant to at least one prior tyrosine kinase inhibitor (TKI) therapy","regulator":"FDA"},{"name":"Chronic Myeloid Leukemia (CML) in adult patients with Philadelphia chromosome-positive (Ph+) disease who are refractory or resistant to at least one prior tyrosine kinase inhibitor (TKI) therapy","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) 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classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"},{"name":"Acute Myeloid Leukemia (AML) in adult patients 60 years or older with at least 30% bone marrow blasts and intermediate-2 or high-risk cytogenetic abnormalities by the European LeukemiaNet (ELN) classification","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_drugWebsite":{"url":"https://www.gmcsf.com","content":"HOME\nABOUT\nEVENTS\nSUPPORT\nNEWS\nAUDITION\nCONTACT\nGAY MEN'S CHORUS OF SOUTH FLORIDA\nFIND TICKETS\nDONATE TODAY\n\n954-763-2266\n\nINVINCIBLE at the Au Rene Theater, Broward Center, June 19, 2026, 8pm\nINVINCIBLE at the Au Rene Theater, Broward Center, June 19, 2026, 8pm\nINVINCIBLE at the Au Rene Theater, Broward Center, June 19, 2026, 8pm\nINVINCIBLE at the Au Rene Theater, Broward Center, June 19, 2026, 8pm\nINVINCIBLE at the Au Rene Theater, Broward Center, June 19, 2026, 8pm\nINVINCIBLE at the Au Rene Theater, Broward Center, June 19, 2026, 8pm\n\nMission: We sing so that LGBTQ+ people can live their truth through quality music experiences that inspire audiences, open minds, change hearts, and affirm our common humanity. Vision: A diverse world united. The Gay Men's Chorus of South Florida (GMCSF) is a vibrant community of voices, blending generations and cultures in harmony with one mission: to shape a brighter, more inclusive future through music. GMCSF stands as a powerful force for advocacy, using the universal language of music to transcend social barriers and uplift the LGBTQ+ community.\n\nHISTORY\n\nWith a roster of over 180 talented singers, GMCSF is the largest gay men's chorus in the southeastern United States and one of the top ten LGBTQ+ choruses in the country. Our grand-scale concerts, meaningful community engagements, and volunteer-driven outreach touch lives throughout South Florida and beyond. Under the direction of Artistic Director Gabe Salazar, GMCSF captivates annually ~35,000 live audience members while welcoming ~72,000 visitors to its growing digital platform, gmcsf.org. \n\n\n\n\nA significant milestone was reached in December 2016 when GMCSF partnered with Seminole Hard Rock Hotel & Casino Hollywood to present its holiday concert at Hard Rock Live. What began as a landmark event has evolved into a dynamic nine-year partnership rooted in music, visibility, and community impact.\n\nPRESS\n\nOur impact reaches from Miami Heat and Miami Marlins Pride Nights to the I"},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02923778","phase":"PHASE2","title":"Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-12-31","conditions":"Leiomyosarcoma, Liposarcoma, Sarcoma G2","enrollment":40},{"nctId":"NCT02978625","phase":"PHASE2","title":"Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2017-09-27","conditions":"Anaplastic Large Cell Lymphoma, 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